Regulatory Digital Platform Consultant

Highly Competitive
  1. Permanent
  2. Consultant / Specialist
  3. United States
Lansing, Michigan
Posting date: 12 Mar 2019
RA.MJ.22149_1552389259

ProClinical is advertising a vacancy for a Regulatory Digital Platform Consultant position with one of the largest workforce management solutions companies in the world. Specialising in multiple scientific and engineering sectors, this organization is seeking for the Platform Consultant to join them on a remote basis and provide expertise through online means.

Job Responsibilities:

  • Developing the overall regulatory strategy for digital technologies and digital solutions including web and mobile enabled applications that interface to RWD.
  • Partnering with R&D and other Digital Platform COE leaders as well as other Medical Device Regulatory leaders to develop and implement strategy for digital platform pipeline development.
  • Ensuring the timely regulatory clearances/registration in support of digital technology product launches in all strategic markets.
  • Regularly communicating with business unit Regulatory Affairs leaders to ensure aligned and coordinated regulatory strategies for digital projects managed within specific business.
  • Providing progress updates to key R&D and other business stakeholders on a regular and as-needed basis.
  • Partnering with the Regulatory Affairs and Policy Intelligence team to monitor the regulatory environment globally and providing assessments to COE management of the impact of new and changing regulation son the Centre of Excellence's research and development programs.

Skills and Requirements:

  • At least a B.A./B.S. within a technical related discipline is required, with an M.S., J.D., Ph.D., or M.D. a plus.
  • Previous experience in a software driven product portfolio inclusive medical device environment is required.
  • A demonstrable track record of flawless execution is required.
  • Demonstrable success in partnering and influencing across a matrix environment is required.
  • A proven track record of formulating global regulatory strategies that align with business deliverables.
  • Experience in digital or digital health would be a plus.
  • A history of working in start-up environments or organisations with an Agile culture is a plus.
  • Previous experience with advanced technologies, i.e., Data Science, Wearable Devices, Sensors, and/or Robotics is desirable.
  • Capable of leveraging relations with key constituents to deliver tangible results and clinical insights.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.
  • Entry Level.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Mary Jacobs at +267-477-4800, or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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